Protective CE
What is the Personal Protection Directive?
Personal protective equipment is PPE. It is mainly used to protect employees from serious occupational injuries or diseases caused by exposure to chemical radiation, electric equipment, human equipment, mechanical equipment or in some dangerous workplaces. In addition to face masks, safety glass, safety hats, safety shoes, personal protective equipment includes a large number of respiratory protection equipment, protective clothing. These include safety hats, goggles, hearing protectors, safety gloves, safety shoes, respirators and seat belts.
1.Who can help manufacturers sell PPE in the EU?
In the European Union (EU), engineering experts can help design and produce PPEs that meet EU requirements and are standard for delivery to the EC market. Foreign manufacturers can also sell PPE with the help of local private and public institutions that specialize in exporters. The mission of Europa is to evaluate compliance with directives and to assist in assessing specific issues. Usually, the agency will provide help and information on standards. In the case of explaining production doubts, the manufacturer set up in the EC should contact the national authorities responsible for PPE.
2.Is the PPE Directive mandatory for all EU member states?
The answer is yes. Since July 1995, it has become a legal text enforced by all EU member states. PPE Directive 89/686/EEC was adopted on February 21, 1989 and became the law of the European Community on July 1, 1992. The transition period lasted until June 30, 1995.
3.Will the national laws concerning PPE change?
In every member state of the European Union, national laws relating to PPE must be transformed into PPE directives and adopted in accordance with the principle of "complete consistency". In other words, all countries in Europe (including the European Economic Area) have to convert PPE directives in the same way. Therefore, PPE must comply with the health and safety requirements and related certification procedures stipulated in the revised PPE Directive.
4.How to understand whether the protective equipment is required by PPE instructions?
The characteristics of protective equipment, anticipated protective uses and manufacturers'declarations of protection can be found in some catalogues of advertisements and business information, as well as in manufacturer's websites and similar publications and publications. The relevant provisions of the PPE Directive are as follows.
Article 1 of the PPE Directive provides that:
1.2 According to the provisions of the Directive, PPE refers to the appliances or equipment worn and equipped by individuals to protect one or more hazards to health and safety. PPE also covers the following aspects:
(a) A device assembled by a manufacturer of several devices or devices for individual protection against one or more possible and simultaneous hazards.
(b) Separable and inseparable protective periods or appliances combined with individual non-protective equipment worn and equipped by individuals for special tasks.
(c) It basically meets the functional requirements and is dedicated to interchangeable PPE devices for such devices.
1.3 External systems connected to PPE, even if users wear and equip for a long time, will be considered as a component of the device.
1.4 This instruction is not suitable for the PPE involved in other instructions. This is because the directive involves the free flow and security of goods on the market. In particular, equipment-related instructions 96/98/EEC are used throughout the EC.
5.How does the manufacturer meet the requirements of PPE instructions?
Individual protective equipment covered by the definition of Article 1 above must meet the corresponding basic health and safety requirements specified in Appendix 2 in order to prove that appropriate health protection and safety are provided for users. PPE instructions are part of the "new approach" and these requirements are expressed in general terms. The directive also stipulates some requirements related to marketing, such as certification, conformity statement, logo, user information, etc.
6 What is the "new method" regulation?
PPE directives are part of what is known as "new method" directives, which are generated by the same principles and common methods. The key point of the "new approach" principle is that it provides legal liability for the general principle of "basic health and safety requirements". Manufacturers can use uniform standards to demonstrate compliance with basic health and safety requirements. Products manufactured in accordance with the New Method Directive must be attached with the CE logo. The basic principles of the New Method Act are explained in detail in the "Guidelines for Annual Method Directives".
7.What is the meaning of CE logo? Is it mandatory?
The personal protective equipment attached with CE marks indicates that it meets the health and safety requirements of PPE and other instructions. It is mandatory to attach CE flags to the PPE contained in instruction 89/686/EEC.
8.How to prove the conformity with PPE instructions?
According to the compliance statement, the requirement for the manufacturer is to increase the relative simplicity of category 1 to more detailed procedures of category 2 and 3. The definition of PPE type is given in Article 8 of the instruction.
Category 1 (Minimum Risk)
This category sometimes involves "self-assurance" because the manufacturer does not need to publish the agency's services. But the manufacturer must satisfy the following conditions:
A. Ensure that its products meet basic health and safety requirements. (Appendix 2)
B. Technical style of compilation (clause 8 and appendix 3).
C. Draft a declaration of product conformity (clause 12 and appendix 6).
D. Attach CE logo (clauses 12 and 13 and appendix 4).
Category 2 (Standard PPE) What is the Personal Protection Directive?
Personal protective equipment is PPE. It is mainly used to protect employees from serious occupational injuries or diseases caused by exposure to chemical radiation, electric equipment, human equipment, mechanical equipment or in some dangerous workplaces. In addition to face masks, safety glass, safety hats, safety shoes, personal protective equipment includes a large number of respiratory protection equipment, protective clothing. These include safety hats, goggles, hearing protectors, safety gloves, safety shoes, respirators and seat belts.
1.Who can help manufacturers sell PPE in the EU?
In the European Union (EU), engineering experts can help design and produce PPEs that meet EU requirements and are standard for delivery to the EC market. Foreign manufacturers can also sell PPE with the help of local private and public institutions that specialize in exporters. The mission of Europa is to evaluate compliance with directives and to assist in assessing specific issues. Usually, the agency will provide help and information on standards. In the case of explaining production doubts, the manufacturer set up in the EC should contact the national authorities responsible for PPE.
2.Is the PPE Directive mandatory for all EU member states?
The answer is yes. Since July 1995, it has become a legal text enforced by all EU member states. PPE Directive 89/686/EEC was adopted on February 21, 1989 and became the law of the European Community on July 1, 1992. The transition period lasted until June 30, 1995.
3.Will the national laws concerning PPE change?
In every member state of the European Union, national laws relating to PPE must be transformed into PPE directives and adopted in accordance with the principle of "complete consistency". In other words, all countries in Europe (including the European Economic Area) have to convert PPE directives in the same way. Therefore, PPE must comply with the health and safety requirements and related certification procedures stipulated in the revised PPE Directive.
4.How to understand whether the protective equipment is required by PPE instructions?
The characteristics of protective equipment, anticipated protective uses and manufacturers'declarations of protection can be found in some catalogues of advertisements and business information, as well as in manufacturer's websites and similar publications and publications. The relevant provisions of the PPE Directive are as follows.
Article 1 of the PPE Directive provides that:
1.2 According to the provisions of the Directive, PPE refers to the appliances or equipment worn and equipped by individuals to protect one or more hazards to health and safety. PPE also covers the following aspects:
(a) A device assembled by a manufacturer of several devices or devices for individual protection against one or more possible and simultaneous hazards.
(b) Separable and inseparable protective periods or appliances combined with individual non-protective equipment worn and equipped by individuals for special tasks.
(c) It basically meets the functional requirements and is dedicated to interchangeable PPE devices for such devices.
1.3 External systems connected to PPE, even if users wear and equip for a long time, will be considered as a component of the device.
1.4 This instruction is not suitable for the PPE involved in other instructions. This is because the directive involves the free flow and security of goods on the market. In particular, equipment-related instructions 96/98/EEC are used throughout the EC.
5.How does the manufacturer meet the requirements of PPE instructions?
Individual protective equipment covered by the definition of Article 1 above must meet the corresponding basic health and safety requirements specified in Appendix 2 in order to prove that appropriate health protection and safety are provided for users. PPE instructions are part of the "new approach" and these requirements are expressed in general terms. The directive also stipulates some requirements related to marketing, such as certification, conformity statement, logo, user information, etc.
6 .What is the "new method" regulation?
PPE directives are part of what is known as "new method" directives, which are generated by the same principles and common methods. The key point of the "new approach" principle is that it provides legal liability for the general principle of "basic health and safety requirements". Manufacturers can use uniform standards to demonstrate compliance with basic health and safety requirements. Products manufactured in accordance with the New Method Directive must be attached with the CE logo. The basic principles of the New Method Act are explained in detail in the "Guidelines for Annual Method Directives".
7.What is the meaning of CE logo? Is it mandatory?
The personal protective equipment attached with CE marks indicates that it meets the health and safety requirements of PPE and other instructions. It is mandatory to attach CE flags to the PPE contained in instruction 89/686/EEC.
8. How to prove the conformity with PPE instructions?
According to the compliance statement, the requirement for the manufacturer is to increase the relative simplicity of category 1 to more detailed procedures of category 2 and 3. The definition of PPE type is given in Article 8 of the instruction.
Category 1 (Minimum Risk)
This category sometimes involves "self-assurance" because the manufacturer does not need to publish the agency's services. But the manufacturer must satisfy the following conditions:
A. Ensure that its products meet basic health and safety requirements. (Appendix 2)
B. Technical style of compilation (clause 8 and appendix 3).
C. Draft a declaration of product conformity (clause 12 and appendix 6).
D. Attach CE logo (clauses 12 and 13 and appendix 4).
Category 2 (Standard PPE)
A, b, C and D measures are required. Measures C and D require EC type inspection certificates, for which the manufacturer must:
E. Apply to the publishing agency for type inspection (clause 10). If the conditions are met, the publishing agency shall draw up the EC type inspection certificate and the comrade manufacturer's certificate shall take effect.
Category 3 (PPE to prevent fatal or serious and unavoidable hazards)
Require a, b, c, d, e to provide an additional requirement for additional inspection of PPE production in accordance with one or two possible procedures (clause 11A or 11B). These two procedures are as follows:
F1) clause 11A procedure - "EC quality control system for final products". The manufacturer requires the announcement agency to ensure that the PPE manufactured truly meets the requirements of the EC type certificate. This is achieved by random sampling of production samples at least once a year. Then, the test report is issued by the announcement agency.
F2) clause 11B procedure - "the system of ensuring the quality of EC production through testing". The manufacturer shall have a quality control system approved by the announcement body.
9. PPE standard is not mandatory, if understood?
Equipment adopting PPE directives, standards, including the European Uniform Standards, is by no means emphatic. On the other hand, in the context of the implementation of the PPE Directive, the European Commission has published names, bibliographies and updated catalogues of relevant European Uniform Standards in the official publications of the European Community that meet the requirements of Directive 89/686/EEC. Manufacturers who meet this European unified standard and some of its requirements may benefit from the assumption that they meet the basic requirements of the corresponding directive 89/686/EEC.
10. How to adopt the European Uniform Standards?
If the relevant equipment product meets the requirements of the unified standard, it is considered to meet the EHSR requirements related to the PPE Directive (the basic health and safety requirements provided in Appendix 2), further speaking, it meets the standards.
Since each product and each basic requirement does not always meet the corresponding European unified standards, manufacturers must be very careful when verifying that their personal protective equipment meets all relevant requirements of Directive 89/686/EEC. Manufacturers must also comply with other relevant regulatory requirements, such as hazardous substances requirements.
Ⅲ. CE Mark-Personal Protection Directive (PPE) Product Data
Product Appearance Chart
General product design drawings and auspicious drawings are attached with computational data as required and test results of prototype prototypes necessary to verify compliance with basic requirements.
Detailed list of basic health and safety requirements and coordination standards or other technical specifications considered in product design.
The product description is as follows:
Storage, use, cleaning, maintenance, maintenance and disinfection. Cleaning, maintenance and disinfection products recommended for manufacture shall not adversely affect PPE or users when applied in accordance with relevant instructions.
The performance of these PPEs is recorded in technical tests to test the level and level of protection they can provide.
PPE applicable accessories and characteristics of suitable spare parts.
Suitable for different magnitude and dangerous protection level and corresponding service life.
The abandonment or expiration period of PPE or some of its components.
Packaging type suitable for transportation.
Meaning of various signs.
When necessary, that is, when one or more of the EU directives allows manufacturers to select directives ready for application during the transitional period, the CE logo at this time will indicate that only those directives selected by the manufacturer for application are complied with. In this case, details of the applicable instructions need to be provided.
The name, address and identification number of the registered certification authority that has been involved in the design phase of PPE.
The product label
Quality System (Inspection Specification) (ISO 9001 Certificate) (if necessary)
Description of the control and testing facilities used by the manufacturer to inspect PPE products in compliance with harmonized standards or other technical specifications and to maintain quality levels. (if necessary)
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